BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 18360885 · Received December 19, 2023

    Report

    Report Number
    2029046-2023-03000
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 22, 2023
    Report Date
    December 19, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND THEY WERE UNABLE TO PERFORM EMERGENCY PACING. DURING THE PROCEDURE, COULD NOT CONDUCT EMERGENCY PACING FROM THE ABLATION CATHETER FROM THE PACING CABLE. PACING LEADS WERE CONNECTED TO THE PATIENT INTERFACE UNIT (PIU) PRIMARY PACING PORT. NOT ABLATING AT THE SAME TIME. THEY REPLACED TO THE BACKUP PACING CABLE IMMEDIATELY. PACING WAS POSSIBLE, SO IT WAS DETERMINED THAT THE CABLE WAS DEFECTIVE. NO UNINTENTIONAL PACING WAS DETECTED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. DEVICE EVALUATION DETAILS: IT WAS REPORTED THAT DURING TROUBLESHOOTING THEY FOUND THAT THE DEFECTIVE JB PACING AUX CABLE CAUSED THE ISSUE. THE DEFECTIVE JB PACING AUX CABLE WAS REPLACED WITH A HOSPITAL BACKUP CABLE AND THE ISSUE WAS RESOLVED. TECHNICAL SERVICE (TS) CONFIRMED THAT A REPLACEMENT JB PACING AUX CABLE WAS PROVIDED TO THE CUSTOMER. ISSUE IS RESOLVED. THE SYSTEM IS IN SERVICE AND READY FOR USE. IT WAS REQUESTED TO SEND THE DEFECTIVE JB PACING AUX CABLE FOR INVESTIGATION TO THE MANUFACTURER. HOWEVER, IT WAS REPORTED THAT THE DEFECTIVE CABLE HAD BEEN DISCARDED AT THE HOSPITAL. THEREFORE, THE CABLE WAS NOT INVESTIGATED. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM #50569 WAS REVIEWED. NO SIMILAR COMPLAINTS WERE FOUND. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 SYSTEM #50569, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. CORRECTION: THE INCORRECT PMA/ 510(K) NUMBER OF ¿K042999¿ WAS REPORTED IN THE 3500A INITIAL MEDWATCH REPORT UNDER FIELD G4. THE CORRECT NUMBER HAS NOW BEEN ADDED ¿K213264¿. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 20-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING INTENDED PACING WAS DELIVERED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND THEY WERE UNABLE TO PERFORM EMERGENCY PACING. DURING THE PROCEDURE, COULD NOT CONDUCT EMERGENCY PACING FROM THE ABLATION CATHETER FROM THE PACING CABLE. PACING LEADS WERE CONNECTED TO THE PATIENT INTERFACE UNIT (PIU) PRIMARY PACING PORT. NOT ABLATING AT THE SAME TIME. THEY REPLACED TO THE BACKUP PACING CABLE IMMEDIATELY. PACING WAS POSSIBLE, SO IT WAS DETERMINED THAT THE CABLE WAS DEFECTIVE. NO UNINTENTIONAL PACING WAS DETECTED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017311 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 50569

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT (SJM) STIMULATOR| UNKNOWN ABLATION CATHETER| UNKNOWN PACING CABLE